Content of DHF, DMR and DHR for medical device software - Part 2 DMR
医疗器械软件的DHF,DMR和DHR的目录-第二部分 DMR
What is the Device Master Record (DMR)?
什么是医疗器械主记录？
The DMR is a term defined by the US regulations. You can find it in the online copy of 21 CFR on the FDA website.
DMR是一个被US法规定义的术语。你可以在FDA网站上21CFR的在线副本中找到它。
Definition
The ction 21 CFR 820.3(j), gives the definition of DMR:
该章节21 CFR 820.3（j）,给出了DMR的定义：
∙Device master record means a compilation of records containing the procedures and speci
fications for a finished device.
器械主记录指一个完整的记录，包括了已经成品医疗器械的程序和规范。
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Like the DHF, the DMR applies to a finished device.
就像DHF，DMR适用于一个成品医疗器械。秋声
But the DMR is the Device master record. Can you e the difference with the Design history file?
但是DMR是该医疗器械的主记录。你能明白和设计历史文件的不同吗？
The difference resides in the pha of the product lifecycle covered by the concepts. The DHF, this is in its name, covers the design pha. The DMR is ud during the production pha.
不同在于那些概念涵盖的产品的生命周期的阶段。DHF，在它的名字内，涵盖了设计阶段。DMR被用于生产期间。
The DHF contains all the design history, the DMR contains the snapshot of the device specifications validated at the end of the design pha.
DHF包括所有的设计历史，DMR包括在设计阶段的末尾医疗器械规格验证的简要说明。
Production controls
生产控制
Production controls apply to (almost) all medical devices of any class. Especially for medical device software (standalone or embedded) production controls always apply.
This is one practical reason that DMR is required for all medical device software, whichever their class.
生产控制适用于（几乎）任何类别的所有医疗器械。尤其是医疗器械软件（独立或嵌入式）生产控制总是适用的。这是一个主要的原因对所有医疗器械软件都被要求DMR，不管他们是什么类别。
冬春之交
Design transfer
设计转换
The DMR contains the output of the design transfer. 21 CFR 820.30(h) says:
DMR包括了设计转换的输出，21 CFR 820.30(h) 说：
Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
设计转换。每个制造商应建立和保持程序以确保医疗器械设计被正确的转换到生产规范中。
So a design transfer pha or review (or any other provision in your QMS) shall exist to prove that this design transfer actually happens. It shall be bad on the snapshot of the validated design.
因此设计转换阶段或评审（或QMS中的任何其他的条款）应存在于证实设计转换实实在在
发生了。设计转换应基于验证设计的简介。
The scope of the design transfer should contain, depending of your software:
设计转换的范围应包括，取决于你的软件：
∙the software itlf, binaires, scripts, configuration files and so on,
软件本身、进制、脚本、配置文件等等；
∙the technical documentation (software requirements, design and tests, ), output of the design process,
技术文件（软件要求、设计和测试、风险分析.....），设计过程的输出。新生儿消化不良
∙any other document uful to the end-urs, administrators, technical personnel,
任何其他的文档对终端用户、管理员、技术人员、支持人员。。。。。
But the DMR is more than that.
但是DMR比那更多。
林徽因传Device Master Record 器械主记录
There is a ction in the 21 CFR, which lists mandatory records for medical devices: 21 CFR part 820, subpart M - Records (ctions 180 to 198). This is where we find more data about the DMR.
在21CFR中有一个章节，列举了用于医疗器械的强制记录：21 CFR part 820，M-记录子部分（条款180-198）。是我们找到更多关于DMR数据的地方。
21 CFR 820.181 says (some text stripped):
姜子牙多少岁出山21 CFR 820.181 说 (一些文本被删减了)
∙Each manufacturer shall maintain device master records (...) The DMR for each type of device shall include, or refer to the location of, the following information:
每个制造商应保持器械主记录（...），主记录对每个型号的器械应包括，或参考的位置，下述信息：
oDevice specifications, 器械规范；
oProduction process specifications, 生产过程规范；
oQuality assurance procedures, 质量保证过程
oPackaging and labeling specifications,包装和标签规范
oInstallation, maintenance, and rvicing procedures and methods. 安装、维护保养，和服务程序和方法。
In other words, a DMR is a comprehensive record of all the procedures, instructions and specifications required to manufacture a device. It contains the documents or locations of documents for manufacturing and rvicing a device.
换句话说，DMR是对制造一个医疗器械必须的所有过程，操作指南和规范要求的综合记录。
Though easily understandable for physical devices, this regulation needs a bit of interpretation for standalone software.
尽管对物理医疗器械容易理解，但这个法规对独立软件来说需要一些解释。
开学第一天手抄报Device Master Record content for software
用于软件的器械主记录目录
Let's e how to interpret each bullet of the DMR content.
让我们看看怎么阐释主记录的每个着重点。
Device specifications 器械规格
For software, device specifications could be translated to Software Requirement Specifications at a minimum. But it lacks the architectural and detailed specifications. Thus, device specifications can be extended to the output of the software development process when a device is validated.
>开班仪式主持词
